MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71562-01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An hcp reported a customer experienced an allergic skin reaction on day 3 of wear of the adc freestyle libre pro sensor.The customer presented with "redness and bumps" just on her right arm and self-treated with benadryl, claritin and hydrocortisone cream.A couple of days later, the redness and bumps from the right upper arm had spread and "weeping yellowish" discharge was noted.The customer had hcp contact and was administered an injection of the steroid, kenalog (dose unknown,) and was given a prescription for augmentin (amoxicillin, dose unknown) for treatment.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
Event or Problem Description
An hcp reported a customer experienced an allergic skin reaction on day 3 of wear of the adc freestyle libre pro sensor.The customer presented with "redness and bumps" just on her right arm and self-treated with benadryl, claritin and hydrocortisone cream.A couple of days later, the redness and bumps from the right upper arm had spread and "weeping yellowish" discharge was noted.The customer had hcp contact and was administered an injection of the steroid, kenalog (dose unknown,) and was given a prescription for augmentin (amoxicillin, dose unknown) for treatment.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE PRO
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8440373
• Report Number: 2954323-2019-02333
• Device Sequence Number: 1104595
• Product Code: MDS
• UDI-Device Identifier: 00357599715625
• UDI-Public: 00357599715625
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P150021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 71562-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 120